SURGICOUNT recallZ-2463-2023 · Stryker Corporation · initiated Jul 10, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type
FDA root cause category: Under Investigation by firm
What the company is doing
Stryker issued Urgent Medical Device Correction Letter addressed to: IT Director, Materials Manager, Risk Manager, OR Director, OR Coordinator sent July 10, 2023 via 2-day Fed'X delivery. Letter states reason for recall, health risk and action to take: 1. Immediately review this software update notification. Advise OR staff, and all other personnel who may use this product, of the information in the notification. 2. Ensure all Stryker surgical tablets using Surgicount+ software is connected to the local facility Wi-Fi so that the software update can be automatically transmitted. Press INSTALL once the update notification appears on the tablet to complete the update. Contact your local sales representative or technical support at 1-800-253-3210 for any assistance or questions. 3. Sign and return the enclosed Business Reply Form to [email protected]. 4. Maintain awareness of this communication internally and inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients accordingly. We apologize for any inconvenience this action may cause your facility. Please forward a copy of this letter to any other personnel within your facility that you deem appropriate. Please contact Jordan Anderson at (269) 800-1347 or [email protected] with questions or concerns.
Recall details
- Recall number
- Z-2463-2023
- Status
- Open, Classified
- Initiated by the company
- Jul 10, 2023
- Posted by the FDA
- Aug 25, 2023
- Recalling firm
- Stryker Corporation
- Quantity
- 57 units
- Product code
- PVZ
- Distribution
- US Nationwide distribution.
Product description
SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and recording the number of RFID-tagged absorbent articles used during surgical procedures Product Code: 0694-002-090;
Code information (models, lots, serial numbers)
GTIN 07613327543094 Software Version: 2.1.8 & 2.20
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SURGICOUNT 0694002090Stryker Corporation · Counter, sponge, surgical2 recalls0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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